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NCT02190747 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects
A Phase 2 study, sponsored by Clementia Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT02190747: Completed Phase 2 study, sponsored by Clementia Pharmaceuticals.
NCT02190747 is a Phase 2 study that has completed, run by Clementia Pharmaceuticals. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02190747, a Phase 2 study, has completed, sponsored by Clementia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict movement by locking joints leading to cumulative loss of function and disability. Mouse models of FOP have demonstrated the ability of retinoic acid receptor (RAR) gamma agonists to prevent heterotopic ossification (HO) following injury. The purpose of the study is to evaluate whether palovarotene, an RAR gamma agonist, will prevent HO during and following a flare-up in subjects with FOP.
Primary Outcome
A responder was defined as a subject with no or minimal new heterotopic ossification (HO) at flare-up site versus baseline as assessed by plain radiographs at Week 6. Minimal new HO is defined as new HO with an HO score \<=3 in both anterior/posterior (AP) and lateral projections (or if one view is non-interpretable or non-evaluable, then remaining evaluable view is used). The HO score ranges from 0 to 6 where, 0 = no HO and 6 = single contiguous HO with longest dimension \>2 diameters of refere
Interventions
- DRUG Placebo
- DRUG Palovarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-07-14 |
| Est. Completion | 2016-05-23 |
| Phase | Phase 2 |
What the finished NCT02190747 record still lists
NCT02190747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02190747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02190747 about?
NCT02190747 is a clinical study titled "An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects". Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life and may occur spontaneously or a...
What is the current status of trial NCT02190747?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2014-07-14. Estimated completion is 2016-05-23.
What interventions are being tested in trial NCT02190747?
The interventions under investigation include: Placebo (DRUG), Palovarotene (DRUG).
Who is sponsoring clinical trial NCT02190747?
This trial is sponsored by Clementia Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02190747's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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